ADVANCED ELECTROCARDIOGRAPH

GUDID B510ECG12C1

ADVANCED INSTRUMENTATIONS, INC.

Electrocardiograph, professional, multichannel

• Primary Device ID: B510ECG12C1
• NIH Device Record Key: b129b0b3-a4b1-48fe-8988-41847a195c07
• Commercial Distribution Discontinuation: 2028-04-15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVANCED ELECTROCARDIOGRAPH
• Version Model Number: ECG-12 C
• Company DUNS: 608736880
• Company Name: ADVANCED INSTRUMENTATIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B510ECG12C1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111805

FDA Product Code

• DPS: Electrocardiograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-23
• Device Publish Date: 2020-04-15

On-Brand Devices [ADVANCED ELECTROCARDIOGRAPH]

• B510ECG3PLUS1: ECG-3 PLUS
• B510ECG12C1: ECG-12 C
• B510ECG61: ECG-6
• B510ECG3F1: ECG-3 F
• B510ECG121: ECG-12